MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER; CALCULATOR/DATA PROCESSING FOR CLINICAL USE

Lot Number 8.14.10

Device Problems Incorrect Or Inadequate Test Results (2456); Inadequate User Interface (2958)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  Other  

Event Description

On (b)(6) 2016, (b)(6) was notified by our business partner (b)(6) diagnostics that their customer ((b)(6) health system in (b)(6)) wrote a rule that fired incorrectly and erroneous results were sent to the lis system.A specimen was run, and the initial result was greater than the reportable range of the instrument, with no dilution.The results were rejected by instrument manager and the specimen was automatically diluted by the instrument and rerun.The rerun results were again above the range and rejected by instrument manager.The specimen was diluted again automatically by the instrument and run again.The results of this third run were still above the reportable range for that analyte.The results of the third run should have been held within instrument manager for further action by the lab, but instead the rules rounded the result up to "greater than the reportable range" of the analyzer and released them to the lis.This was discovered later by the lab when a final diluted result came off the analyzer and it was indeed still above the reference range for the test, but not above the reportable range for the analyzer.This issue was caused by a user error of instrument manager.The rule to evaluate the results when they are diluted was written incorrectly, and the validation performed by the site did not defect this issue.The issue was caught before the pt was treated, so there was no harm to the pt specified.The rule in question contains a value list with virtually the entire test menu on the list, which means the rule can fire on more than just the one test in this scenario.The rule has been in place for over one year.Due to the inability to positively verify that no other pt results were affected during the time the rule was in place, this report is being filed.(b)(6) has not received reports of harm but is reporting because pts could have possibly been harmed.

• Brand Name: INSTRUMENT MANAGER
• Type of Device: CALCULATOR/DATA PROCESSING FOR CLINICAL USE
• Manufacturer (Section D): DATA INNOVATIONS LLC; south hurlington VT
• MDR Report Key: 6198459
• MDR Text Key: 63490638
• Report Number: MW5066854
• Device Sequence Number: 1
• Product Code: JQP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 8.14.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1